GSK plc

Jemperli (dostarlimab-gxly) trial continues to show unprecedented results with no evidence of disease in 100% of patients with locally advanced mismatch repair deficient (dMMR) rectal cancer

Retrieved on: 
Montag, Juni 3, 2024

In the first 24 patients evaluated, a sustained clinical complete response with a median follow-up of 26.3 months (95% CI: 12.4-50.5) was observed.

Key Points: 
  • In the first 24 patients evaluated, a sustained clinical complete response with a median follow-up of 26.3 months (95% CI: 12.4-50.5) was observed.
  • These results bring us one step closer to understanding the potential of dostarlimab-gxly in this curative-intent setting for patients with dMMR locally advanced rectal cancer.
  • Dostarlimab-gxly is not approved anywhere in the world for the frontline treatment of locally advanced dMMR rectal cancer.
  • The AZUR-1 trial aims to confirm the findings of the supported collaborative study in locally advanced dMMR rectal cancer led by Dr. Cercek at MSK.

Belantamab Mafodotin combination reduced the risk of disease progression or death by nearly 50% versus standard of care combination in relapsed/refractory multiple myeloma

Retrieved on: 
Sonntag, Juni 2, 2024

At a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the belantamab mafodotin combination compared to 12.7 months (95% CI: 9.1-18.5) in the bortezomib combination.

Key Points: 
  • At a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the belantamab mafodotin combination compared to 12.7 months (95% CI: 9.1-18.5) in the bortezomib combination.
  • At the end of one year, 71% (95% CI: 63-78) of patients in the belantamab mafodotin combination group compared to 51% (95% CI: 42-60) in the bortezomib combination group were alive and had not progressed.
  • At the end of one year, 83% (95% CI: 76-88) of patients were alive in the belantamab mafodotin combination group versus 76% (95% CI: 68-82) in the bortezomib combination group.
  • The safety and tolerability profile of the belantamab mafodotin combination was broadly consistent with the known profile of the individual agents.

Recommendation from Equinor's nomination committee

Retrieved on: 
Dienstag, Mai 28, 2024

The nomination committee in Equinor ASA (OSE:EQNR, NYSE:EQNR) recommends that the company's corporate assembly elects Tone Hegland Bachke and Fernanda Lopes Larsen as new members to the board of directors of Equinor ASA.

Key Points: 
  • The nomination committee in Equinor ASA (OSE:EQNR, NYSE:EQNR) recommends that the company's corporate assembly elects Tone Hegland Bachke and Fernanda Lopes Larsen as new members to the board of directors of Equinor ASA.
  • Furthermore, the nomination committee recommends a re-election of Jon Erik Reinhardsen as chair and Anne Drinkwater as deputy chair of the board, in addition to re-election of Jonathan Lewis, Finn Bjørn Ruyter and Haakon Bruun-Hanssen as members of the board of directors.
  • The current members, Rebekka Glasser Herlofsen, member since 2015, and Tove Andersen, member since 2020, will resign from the board of directors.
  • Board member Mikael Karlsson, who was elected as of 1 April 2024, is not up for election.

FTC Expands Patent Listing Challenges, Targeting More Than 300 Junk Listings for Diabetes, Weight Loss, Asthma and COPD Drugs

Retrieved on: 
Dienstag, Mai 28, 2024

These patent listings are currently listed in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book, which lists drug products approved by the FDA as safe and effective.To promote competition, the FTC said it is disputing these patent listings as improper or inaccurate.

Key Points: 
  • These patent listings are currently listed in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book, which lists drug products approved by the FDA as safe and effective.

    To promote competition, the FTC said it is disputing these patent listings as improper or inaccurate.

  • Improper Orange Book patent listings can delay cheaper generic alternatives from entering the market, keeping brand name drug prices artificially high.

    “By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” said FTC Chair Lina M. Khan.

  • The Commission’s November challenges led to Kaleo Inc., Impax Labs, GlaxoSmithKline, and Glaxo Group delisting patents in response to the FTC’s warning letters.
  • According to the policy statement, costs associated with challenging improperly listed patents can disincentivize investments in developing generic drugs, which risks delaying or thwarting competitive generic alternatives.

Hornet Therapeutics emerges from stealth with data published in Science demonstrating the first potential drug intervention for Epstein-Barr Virus (EBV) driven disease

Retrieved on: 
Donnerstag, Mai 23, 2024

Targeting this pathway with an IDO-1 inhibitor hinders B cell transformation and EBV-driven pathogenesis in vitro and in animal models in vivo.

Key Points: 
  • Targeting this pathway with an IDO-1 inhibitor hinders B cell transformation and EBV-driven pathogenesis in vitro and in animal models in vivo.
  • The groundbraking findings reported in Science point at IDO-1 inhibition as a potential treatment mechanism for pathologies related to EBV latency.
  • Professor Christoph Hess, founder and Chief Scientific Officer at Hornet Therapeutics added: “In a landmark paper published 60 years ago, Drs.
  • Our data demonstrate that HTX-201 has the potential to hinder EBV latency in its primary host cells, the B cells.

Whitefort Capital Publishes Open Letter to Arbutus Biopharma Shareholders Outlining Paths to Maximize Value

Retrieved on: 
Freitag, Mai 17, 2024

Whitefort Capital Management, LP (together with its affiliates, “Whitefort Capital,” “us” or “we”), which is a long-term investor and the second largest shareholder of Arbutus Biopharma Corp. (NASDAQ: ABUS) (“Arbutus” or the “Company”) with an ownership interest of approximately 6.8% of the Company’s outstanding shares, today published an open letter to shareholders outlining its views of the best paths forward to maximize value.

Key Points: 
  • Whitefort Capital Management, LP (together with its affiliates, “Whitefort Capital,” “us” or “we”), which is a long-term investor and the second largest shareholder of Arbutus Biopharma Corp. (NASDAQ: ABUS) (“Arbutus” or the “Company”) with an ownership interest of approximately 6.8% of the Company’s outstanding shares, today published an open letter to shareholders outlining its views of the best paths forward to maximize value.
  • Whitefort is a long-term investor in Arbutus, having continuously held shares since October 2022.
  • We also want to ensure that the Board of Directors (the “Board”) and our fellow shareholders understand the urgency of these issues.
  • However, we believe that Arbutus should firmly commit to cease any further share issuances for the foreseeable future, including under the ATM program.

enGene Announces the Election of Paul Hastings and Wouter Joustra to its Board of Directors

Retrieved on: 
Mittwoch, Mai 15, 2024

enGene’s Board is now comprised of seven members including Richard Glickman (Chairman), Gerald Brunk, Jasper Bos, and Jason Hanson.

Key Points: 
  • enGene’s Board is now comprised of seven members including Richard Glickman (Chairman), Gerald Brunk, Jasper Bos, and Jason Hanson.
  • “We are pleased to welcome Paul and Wouter to our Board of Directors.
  • “The Company is well-positioned for success, and I look forward to working with the management team to execute its vision.”
    Mr. Joustra said, “I’m thrilled to join enGene’s Board of Directors.
  • Currently Mr. Joustra serves on the board of directors of VectorY Therapeutics and holds a position as a board observer at NewAmsterdam Pharma N.V. (NASDAQ: NAMS).

ReCode Therapeutics Announces Appointment of Dean J. Mitchell as Chairman of Its Board of Directors

Retrieved on: 
Montag, Mai 13, 2024

ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, today announced the appointment of Dean J. Mitchell as chairman of its Board of Directors.

Key Points: 
  • ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, today announced the appointment of Dean J. Mitchell as chairman of its Board of Directors.
  • Mr. Mitchell is a highly experienced and well-regarded biotechnology and pharmaceutical industry veteran who brings over three decades of experience as a board director and corporate executive to the ReCode board.
  • Mr. Mitchell previously served as board chairman of Kinnate Biopharma, Inc. until its sale in 2024 and as board director for ImmunoGen, Inc. until its sale in 2024.
  • He served as executive board chairman for Covis Pharma Holdings until its sale in 2020 and board chairman of PaxVax Corporation until its sale in 2018.

Mersana Therapeutics Provides Business Update and Announces First Quarter 2024 Financial Results

Retrieved on: 
Donnerstag, Mai 9, 2024

ET

Key Points: 
  • ET
    CAMBRIDGE, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today provided a business update and reported financial results for the first quarter ended March 31, 2024.
  • Mersana plans to share initial dose escalation and backfill cohort data and initiate the expansion portion of the trial in the second half of 2024.
  • Collaboration revenue for the first quarter of 2024 was $9.2 million, compared to $7.8 million for the same period in 2023.
  • ET to discuss business updates and its financial results for the first quarter of 2024.

BioVersys Announces Expansion of Strategic Collaboration With GSK and Extension of Its Series C Round by CHF 12.3 Million

Retrieved on: 
Dienstag, Mai 7, 2024

The compound represents a totally new concept of overcoming resistance and significantly potentiating the activity of an existing antibiotic, ethionamide (Eto).

Key Points: 
  • The compound represents a totally new concept of overcoming resistance and significantly potentiating the activity of an existing antibiotic, ethionamide (Eto).
  • As part of the expanded collaboration, GSK will take an equity stake in BioVersys' latest investment round.
  • Adding to further investments from existing and new investors, this extends the Series C financing by CHF 12.3 million, resulting in total proceeds of CHF 44.9 million for the Series C round to date.
  • Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: "We are very pleased to announce both the expansion of our highly successful strategic collaboration with GSK and our partner’s participation in our latest financing round.